Media Hype | ESi Bio | CIRM's Chairman

Along with the full schedule of simultaneous science sessions, showcases, exhibitors and posters - there were a couple of dedicated media presentations which were part of the organizers’ outreach effort. One such presentation was directed at delving into the social and ethics issues surrounding experimental stem cell treatments. Always a topical issue, more so now perhaps as the sector is growing and initial advances are being reported. There is still a long way to go before a full range of approved therapeutics are available and as such it’s a challenge to ensure the public is informed accurately. As a dedicated society for the sector the ISSCR is a leading voice and active participate in the collaborative management of an internationally complex set of issues to ensure safe and beneficial treatments are correctly positioned to the public.

This challenge is not solely the domain of a few industry organisations but, as the media presentation panel members suggest, is the multi-faceted community at large’s responsibility to build the bridges between the science and the patients seeking solutions.   

The title of the event Promise, Progress and Hype reflected the content of the presentations by the speakers who were “representatives involved at home and internationally in ethical, social and patient care issues associated with stem cell science and experimental treatments.”

Jeremy | Tim | Ira | Dan | Megan
Moderator: Jeremy Sugarman, M.D., M.P.H., M.A., John Hopkins Berman Institute of Bioethics,

Panelists: Timothy Caulfield, LL.M., Health Law Science Policy Group, University of Alberta, Ira Herrmann, Stem Cell Network NRW, Düsseldorf, Dan Kaufman, M.D., Ph.D., University of Minnesota, Megan Munsie, Ph.D., Stem Cells Australia.

A featured aspect of the talk was the new “Closer Look at Stem Cells” website, which is “an online resource to help patients and their families make informed decisions about stem cell treatments, clinics and their health.” This portal will look to serve as a gateway to the public and hopefully bridge the gap that exists from a patient’s perspective in fully understanding the potential and what is currently being developed, in the clinic, and to inform as to the pitfalls of the commercial treatments being offered in unregulated environments. A comprehensive ISSCR Patient Handbook is available via their website.

A few quotes from the media literature on the topic:

“I am often contacted by patients struggling with very difficult decisions about their health, and who want to know more about the potential of stem cells,” said Larry Goldstein, a stem cell scientist at the University of California, San Diego and a member of the ISSCR task force responsible for the website expansion. “My experience is that understanding the current state of stem cell science and medicine is key to making informed decisions about stem cell treatments, and so I encourage patients to start their journey on the ‘Closer Look at Stem Cells’ website.”

“The ‘Closer Look at Stem Cells’ website is a direct channel from researchers to the public,” said Megan Munsie, a scientist with Stem Cells Australia and chairperson of the ISSCR task force responsible for the website expansion. “Promising clinical trials are underway for many diseases and conditions, but most stem cell-based treatments are still in the future. We hope that the website will foster interest and excitement in the science, but also an understanding of the current limitations of stem cells as medicine and a healthy skepticism of clinics selling treatments.”

On a number of fronts the community is making a serious effort to tackle the issues head-on and make forward progress in meeting the public’s request for information and feedback. There is nothing worse that being in a desperate situation without knowledge nor recourse so from my perspective it’s a fundamentally important part of the puzzle that requires outreach and more outreach. I’m encouraged to see such great work being done on this topic from the centre…

My observational notes -

One point I had was related to the subjective nature of informed consent in varied jurisdictions and the perception of model systems being applicable to the whole when nature is a diverse set of realities - economic, societal, ethical and legal are few that define the difference…

Also, patient criteria for treatment success varies widely - even in the west. Beyond informed consent there is the reality of moderate to ineffective solutions being sold on the basis of overreach in a commercial setting, which can equally be applicable to many industries. Right to Try is a grassroots call for solutions - can that momentum can be a driver for positive restructuring is the op. How expansive will any net be in curtailing safe product approvals with less that optimal results that don't meet expectations due to exploitive sales tactics? Can and should the industry itself push to establish minimum stem cell treatment criterias for efficacy before products are approved by regulators? What about those countries that don't follow the internationally agreed guidelines? Lot’s of Qs here…

Onto an exhibitor which caught my attention, ESi Bio, a division of BioTime. I was curious to understand more about their positioning and science, beyond their being a leading hESC source & derivative progenitor cell line service provider and some of the historical industry interconnections.

First off I got the division mixed up with the Singapore subsidiary ES Cell Int. (“ESI”), under the same corporate umbrella. ESI Bio in San Diego is the management & technical team working alongside BioTime corporate and arm’s length from ES Cell International in Singapore, an acquired subsidiary of BioTime. However, the ESI Singapore products are the interconnect as the San Diego team are marketing their cell line. Recent deals with the UK, Inserm in France and City of Hope/CIRM in CA were all driven by this San Diego team. I met with Stephanie & James plus a couple of the group’s support scientists & a marketing exec.

A few take-aways from the chats I had with the team and the more detailed biz review meeting I had with Stephanie & James -

  • Biotime is a diverse and interwoven company with many moving parts
  • hESC lines & progenitors are known and entering the market now with 3rd party program deals starting to be publically announced. This is an indication of the growing interest in hESC translational sci.
  • iPS developer kits using mRNA are being positioned as a product rather than a service
  • BioLamina and BioTime/ESi have a link, in what shape or form wasn’t expanded on
  • BioTime considers it a good faith gesture to have a License to Japan Academia’s iPS tech for mRNA derivation even though there is an acknowledged freedom to operate scope in the sector. Michael West et al’s history with OCT4 in early reprogramming work was noted.    
  • The overall umbrella of BioTime & its technology base is leading edge - from it’s Hydrogel tech, to it’s Pluripotent cell derivation technology, LifeMap et al to its proprietary therapeutics and diagnostic subs..

To finish up this post I wanted to relay some thoughts on the meeting I had with one of the Industry’s leaders, Mr. Jonathan Thomas, Chairman of CIRM.

Prior to ISSCR2015 I had sent a short note to Kevin McCormack to ask who was attending, as I wished to introduce myself. Kevin relayed, in his engaging manner, than he couldn’t find an excuse to justify making it over but that Mr. Thomas and Dr. Mills were attending and would no doubt be happy to meet up. Unfortunately Dr. Mills couldn’t attend the event so I arranged to talk with Mr. Thomas.

Of course being interested in Swedish culture we coincidentally found ourselves in the same mode at the same time prior to the show - touring the old city. The difference being I was solo and Jon was touring with an entourage and had a guide pointing things out - very cool! I of course recognised the stature and mustache from afar, while having a juice and muffin at a cafe on the central square.
Next was the opening plenary sessions which were held in the main forum which holds 3000+, a great space which was packed for a number of sessions during the event. I like to sit on the aisle at these presentations, nearish to rear, so I can move when necessary without disturbing anyone. Well here we go again, Jon turns up and does the same thing - sits on the aisle on the other side! Funny I thought.

Next day I meet a classic American gentleman - one which I can only describe as resembling a favorite actor of mine, Sam Elliot, and a dear family friend of my Mother’s whom I'll be visiting in Normandy next month (same moustache and stature - minus the grey!).

Given Jon was evidently busy I didn’t wish to delay him too much and introduced myself and relayed a few strategic thoughts, as per the CIRM’s outreach request, and offered my assistance in any way to further the good cause.

My strategic plan thoughts related to -

  • Method of Action research shouldn’t delay translational benefits to patients if safe
  • More International collaborations
  • Need for new financing model for the industry. Existing reliance on Pharma model not proving to be effective for SC industry. De-Risking via territorial pre-sales suggested and control destiny more w/ marketing/distribution partnerships with Pharma (win/win).
  • Public engagement needs to be a priority, alongside Advocacy group participation. Direct contact and awareness factor - translating & bridging science.
  • Alpha Clinics as a managed route to market can be expanded through out-of-state activities, franchising and a branded accreditation program. Control destiny again.
  • First Look schemes for Pharma/Bio for tie-in & info-flow.
  • IP participation/partnerships, ROI.

I’m sure most if not all of these discussions points have been considered, especially the finance modelling, given leadership’s background. I was pleased to see a Town Hall announcement for the excellent CIRM HIV programs on the public awareness front. I trust inflection will happen but good to have plan B & C….

Well that does it for now - I’ll be writing more next week and wish everyone in the US a happy Independence Day holiday weekend. Here I’m off the the mountains, as it’s stiflingly hot and humid at the moment, to cook some burgers for the family (must remember the Heinz!).